- Abbott (Minneapolis, MN)
- …submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders. ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities. Evaluate risk… more
- Cleerly (Denver, CO)
- …States and account for geography when determining base salary. Responsibilities (General) Regulatory Submissions & Liaison: Prepare, review , and complete ... regulatory agencies (eg, FDA, Health Canada, Europe), and communicate with regulatory authorities throughout the development and review of submissions. Define… more
- Interactive Brokers (Washington, DC)
- …with IBKR's Regulatory Correspondence (RC) team to respond to routine regulatory inquiries Review , oversee, and provide legal advice regarding IBKR's ... is an exciting opportunity to join IBKR's growing Legal Department. The Regulatory Correspondence Counsel will oversee and provide legal input regarding various … more
- Katalyst HealthCares and Life Sciences (Chula Vista, CA)
- …the review of Traditional 510(k) Premarket Notifications. Interact with regulatory agency reviewers as well as distribution partners to facilitate product ... lifecycle. Interpret applicable standards, regulations, and directives to ensure global regulatory compliance. Review product labeling for global compliance.… more
- Katalyst HealthCares and Life Sciences (Skaneateles Falls, NY)
- …responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data ... perform other duties assigned. Track of status and progress of regulatory documentation. Review , edit and proofread regulatory documentation. ssist in… more
- Abacus Service Corporation (Princeton, NJ)
- …for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions documents electronically to ensure all ... Regulatory requirements are met. Major Accountabilities *Support review and approval of OPDP submission documents such as Important Safety Information (ISI)… more
- Michael Page (Skokie, IL)
- …FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other relevant global regulatory bodies. Labeling & Claims Review : Oversee the review and ... innovation, and integrity. Renowned for their steadfast commitment to quality, regulatory compliance, and consumer trust, they create cutting-edge products that not… more
- Santander Holdings USA Inc (Dallas, TX)
- …to business activity and drivers related to General Ledger balances. Prepare or review regulatory reports and research to resolve discrepancies or significant ... of accounting practices and procedures, including US GAAP/IFRS and regulatory reporting standards. Practical analytical and accounting skills. Excellent… more
- NY CREATES (Albany, NY)
- …facilities, semi-conductor tools and support equipment with respect to site and applicable regulatory standards. Managing the review and comment on third party ... safety engineers and industrial hygienists. This will include managing the review of drawings/plans for construction of new facilities, semi-conductor tools and… more
- Abbott (San Diego, CA)
- …submit applicable reports and responses to regulatory authorities. Negotiate with regulatory authorities during the development and review process to ensure ... working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in… more
- EverBank (Irvine, CA)
- …leadership on potential risks or strategic pivots Experience preparing and overseeing review and challenge of regulatory reports, disclosures, and filings High ... Regulatory Affairs Manager The Regulatory Affairs Manager will be responsible for managing the bank's interactions with regulatory agencies and ensuring that… more
- Packaging Corporation of America (Lake Forest, IL)
- … regulatory compliance at PCA's manufacturing operations. Dimensions: Provide detailed regulatory review , guidance and implementation assistance for new and ... locations for PCA's Corporate Environmental Department. Position provides environmental regulatory support, conducts environmental training, conducts environmental audits, develops… more
- Medpace, Inc. (Irving, TX)
- …forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review ; Medical device and/or investigational product/drug ... in multiple therapeutic areas Work within a team of therapeutic and regulatory experts Defined CRA promotion and growth ladder with potential for mentoring… more
- Abbott (Alameda, CA)
- …charges. Review and approve labeling to ensure compliance. Represent regulatory affairs in product recall and recall communication process in APAC. Provide ... to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure… more
- Klick (Philadelphia, PA)
- …creative content for oncology campaigns, including familiarity with medical and regulatory review processes. Comfort with and enthusiasm for integrating ... materials to ensure consistency with brand guidelines and adherence to medical and regulatory standards. Storytelling and Strategy : Works with the art partner to… more
- Atrium Medical (Hudson, NH)
- …Director with regulatory strategy/plans and requirements. Prepares worldwide regulatory submissions/registrations. Participates in the review and disposition ... for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs… more
- BioSpace (Florham Park, NJ)
- …applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with ... of a team. Lead/develop statistical strategy for project development and regulatory submission. Provide statistical leadership for design, analysis and reporting for… more
- Kyowa Kirin North America (Princeton, NJ)
- … Regulatory Affairs, Advertising and Promotion Compliance will independently review , approve, and monitor product advertising and promotional labeling material ... as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product… more
- Cedars Sinai (Los Angeles, CA)
- …data analysis skills and sound statistical analysis methodologies to prepare data for regulatory review (Minitab, JMP or MedStat). About Us Cedars-Sinai is a ... project milestones including, but not limited to, design verification testing, regulatory submission and product launch of initial concepts and future iterations… more
- Kyyba, Inc. (Jersey City, NJ)
- …banking, markets activities, bank regulatory matters etc.,). *Ability to review regulatory obligations in relation to policies and procedures. controls ... The role of the US Compliance RICM AVP includes: *Timely review and analysis of regulatory developments including regulatory changes issued by state and… more
